Patent Cooperation Treaty (PCT) · Office recertified its QMS according to the Standard ISO9001:2015 on September 28th 2016. 1. LEADERSHIP AND POLICY ... policy is established by

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ORIGINAL: ENGLISHDATE: DECEMBER 15, 2017

Patent Cooperation Treaty (PCT)

Common Quality Framework for International Search and Preliminary Examination

INITIAL REPORT ON QUALITY MANAGEMENT SYSTEMS prepared by the Swedish Patent and Registration Office (PRV) (Changes marked in red)

The Authority should provide general background information relevant to the quality management system

(QMS) as set forth in this template.

The descriptions below each main heading of this template should be considered examples of the type

and arrangement of information that should be included under each heading. Each Authority may provide

additional information beyond that set forth in this template as desired.

INTRODUCTION (PARAGRAPHS 21.01 - 21.03)

In this introduction, each Authority should include a summary of all changes to their quality management

system that have taken place since the previous report on their Quality Management System, and any

other matters considered to be interest in relation to quality management.

If applicable, the Authority may at this point indicate any recognized normative reference or basis for their

quality management system besides Chapter 21, such as ISO 9001, under the heading “Normative

Reference for QMS”

For example: “Normative reference for QMS: ISO 9001, EQS (European Quality System)”

Each Authority should then provide at least the information indicated in the descriptive boxes, under the

following headings

Normative reference for QMS: ISO 9001:2015, EQS. The Swedish Patent Office is compliant with all parts of ISO9001:2015 and EQS. As for section 7 of EQS the independent review mechanism consists of our external review partner engaged for review of our QMS according to ISO 9001. External Review partners are engaged on a three year basis. As a complement to our QMS system, strategic planning for the patent department is based on “Balanced

Updated Report on Quality Management Systems by Fel! Hittar inte referenskälla. December 15, 2017 page 2

Scorecard”, clearly defining short and long term goals for the department. The Swedish Patent Office recertified its QMS according to the Standard ISO9001:2015 on September 28th 2016.

1. LEADERSHIP AND POLICY

21.04 Confirm that the following are clearly documented, and that this documentation is available

internally:

(a) The quality policy established by top management.

(b) The roles and names of those bodies and individuals responsible for the QMS, as delegated

by top management.

(c) An organizational chart showing all those bodies and individuals responsible for the QMS.

21.05 Indicate (e.g. by means of a table) the extent of compatibility between the Authority's QMS and the

requirements of Chapter 21 of these International Search and Preliminary Examination Guidelines.

Alternatively, indicate where the Authority is not yet compliant with these requirements.).

a) The quality policy established by PRV top management is published on PRV Intranet. PRV provides a service statement to our users, on our external web www.prv.se. The statement includes definitions regarding: timeliness, costs and quality on our services. The PRV quality policy is established by top management and published on the internal web PRVision under the name “verksamhetsmanual”.

b)

The Executive Management team has delegated the role as Director Quality Management. This role is vacant since 2017-09-01. The director quality management heads a group of representatives from the different parts of the organization, the quality council, which is presented in the PRV Intranet. The director quality management is responsible of the internal review group as well as contacts with external reviewers.

The Director Quality Management and the quality council, acts as support to management on all levels to ensure the proper function of the QMS. However, all directors and managers are responsible for running the business according to the QMS. The Chief Controller is responsible of strategic and planning issues regarding quality in the Executive Management team.

The body responsible for the QMS, ”kvalitetsrådet”, and the names of it’s members responsible for implementing the QMS, are presented on the internal web.

Updated Report on Quality Management Systems by the Swedish Patent and Registration Office (PRV) December 15, 2017 page 3

c)

The information of the responsibilities for the QMS is not presented in the format of an organizational chart. It is, however, clear from the information for which part of the organization an individual has QMS-responsibilities.

[Sample table, to be amended as necessary]

Chapter 21 requirement Extent of compliance

full part no

21.04 (a) Quality policy available �

(b) Identified roles and names for QMS responsibility �

(c) Organizational chart available �

21.05 Established compatibility of QMS with Chapter 21 �

21.06 (a) Mechanisms to ensure effectiveness of the QMS �

(b) Control of the continual improvement process �

21.07 (a) Communication of management about this standard to staff �

(b) The PCT Guidelines are in line with the Authority's QMS �

21.08 (a) Management reviews take place �

(b) Quality objectives are reviewed �

(c) Communication of quality objectives throughout the Authority �

21.09 (a) Performance of a yearly internal review of the QMS in/to �

Top Management



full part no

(b) determine the extent to which the QMS in based on Chapter 21

�

determine the extent to which S&E complies with PCT Guidelines

�

(c) an objective and transparent way �

(d) using input incl. information according paragraph 21.24 �

(e) recording the results �

21.10 Assurance to monitor and adapt to actual workload �

(i) Infrastructure in place to ensure that a quantity of staff �

(a) sufficient to deal with the inflow of work �

(b) which maintains tech. qualifications to S&E in all technical fields

�

(c) which maintains the language facilities to understand languages according to Rule 34

�

(ii) Infrastructure to provide a quantity of skilled administrative staff

�

(a) at a level to support the technically qualified staff �

(b) for the documentation records �

(iii) Ensuring appropriate equipment to carry out S&E �

(iv) Ensuring documentation accord. to Rule 34 �

(v) (a) Instructions to help staff understand and act accord. the quality criteria and standards

�

(b) Instructions to follow work procedures accurately and they are kept up-to-date.

�

(vi) (a) Training and development program to ensure and maintain necessary skills in search and examination

�

(b) Training and development program to ensure awareness of staff to comply with the quality criteria and standards.

�

(vii) (a) System in place for monitoring resources required to deal with demand

�

(b) System in place for monitoring resources required to comply with the quality standards in S&E

�

21.11 (i) Control mechanisms to ensure timely issue of S&E reports �

(ii) Control mech. regarding fluctuations in demand and backlog �

21.12 (i) Internal quality assurance system for self assessment �



full part no

(a) for compliance with S&E Guidelines �

(b) for channeling feedback to staff �

(ii) System for measurement of data and reporting for continuous improvement

�

(iii) System for verifying the effectiveness of actions taken to correct deficient S&E work

�

21.14 (a) Contact person helping identify best practice between Authorities

�

(b) Contact person fostering continual improvement �

(c) Contact person providing for effective comm. with other Authorities for feedback and evaluation

�

21.15 (i) (a) Appropriate system for handling complaints �

(b) Appropriate system for taking preventive/corrective actions �

(c) Appropriate system for offering feedback to users �

(ii) (a) A procedure for monitoring user satisfaction & perception �

(b) A procedure for ensuring their legitimate needs and expectations are met

�

(iii) Clear and concise guidance on the S&E process for the user �

(iv) Indication where and how the Authority makes its quality objectives publicly available

�

21.16 Established communication with WIPO and designated and elected Offices

�

21.17 QMS of Authority clearly described (e.g. Quality Manual) �

21.18 (a) Documents making up the Quality Manual have been prepared and distributed

�

(b) Media available to support the Quality Manual �

(c) Document control measures are taken �

21.19 (i) Quality policy of the Authority and commitment to QMS �

(ii) Scope of QMS �

(iii) Organizational structure and responsibilities �

(iv) the documented processes are carried out in the Authority �

(v) Resources available to carry out processes and implementing the procedures

�

(vi) a description of the interaction between the processes and the procedures of the QMS.

�



full part no

21.20 (i) Records which documents are kept and where they are kept �

(ii) Records of results of management review �

(iii) Records about training, skills and experience of staff �

(iv) Evidence of conformity of processes �

(v) Results of reviews of requirements relating to products �

(vi) Records of the S&E process carried out on each application �

(vii) Record of data allowing individual work to be tracked �

(viii) Record of QMS audits �

(ix) Records on actions taken re. non-conforming products �

(x) Records on actions taken re. corrective actions �

(xi) Records on actions taken re. preventive actions �

(xii) Records referring to search process documentation �

21.21 (i) Recording of the databases consulted during search �

(ii) Recording of keywords, combination of words and truncations during search

�

(iii) Recording of the languages used during search �

(iv) Recording of classes and combinations thereof consulted during search

�

(v) Recording of a listing of all search statements used in databases consulted

�

(vi) Records about other information relevant to the search �

(vii) Records about limitation of search and its justification �

(viii) Records about lack of clarity of the claims �

(ix) Records about lack of unity �

21.22 Report on its own internal review processes �

21.23-21.25

Additional information on further inputs to its internal reviews �

21.26 Initial report called for by paragraph 21.26 �

21.06 Indicate with reference to the organizational chart those bodies and mechanisms management

uses to ensure:

(a) the effectiveness of the QMS; and

(b) that the process of continual improvement progresses.


a) The effectiveness of the QMS is ensured at least twice a year by Management reviews as stated in ISO9001:2015 9.3.1 The Executive Management team ensures the effectiveness of each process covered by the QMS by a follow up scheme, including the evaluation of each process ability to deliver the quality of service as stated in the service commitment.

b) The progress of continual improvement is ensured at the management reviews. The management reviews are conducted at least twice a year by top management and monthly by the management of the Patent department.

Topics for the management reviews include:

Function of management processes Function of strategic and business plan Function of goals and targets Function of follow-up procedures Function of responsibility and authority distribution Function of development model Risks and opportunities Products and services Customer reactions Non-conformities and improvements Internal reviews External reviews QMS improvements

To ensure effectiveness of our QMS we have “kvalitetsrådet”, the body responsible for the QMS. Further, the process owner is responsible for developing and improving processes. Moreover, we conduct management reviews of the QMS system twice per year. We also have our internal web which is part of the QMS-system and includes tools for management of deviations, suggestions, customer complaints and follow-up and control and continuous improvement of our processes and products with the help of the Deming-wheel (PDCA). To ensure progress of the continual improvement process we set goals for handling deviations, suggestions and complaints and for the output from our processes. The result is followed up during monthly top management meetings, documented on the web, and dealt with a PDCA-approach.

21.07 Indicate how management of the Authority communicates to its staff the importance of meeting

treaty and regulatory requirements including:

(a) those of this standard; and

(b) complying with the Authority's QMS.

a) The importance of meeting treaty and regulatory requirements of PCT Ch 21 is communicated by patent experts, directors and our legal section. The communication is normally oral but in some cases complemented by intranet news flashes or similar.

b) The communication on complying with the authorities QMS is done by designated quality representatives as well as directors/management.


21.08 Indicate how and when top management of the Authority or delegated officers:

(a) conducts management reviews and ensures the availability of appropriate resources;

(b) reviews quality objectives; and

(c) ensures that the quality objectives are communicated and understood throughout the

respective Authority.

a) Management reviews are conducted at least twice a year by the Executive Management team and monthly by the management of the Patent department. b) Quality objectives are reviewed frequently (weekly) at management meetings, the effectiveness of actions taken are evaluated at the management reviews. c) Quality objectives are communicated weekly by management meeting protocols and by examiner meetings. Top management conducts reviews during monthly meetings. The meetings include follow up of resource availability and quality objectives. The quality objectives are communicated within the Authority through staff meetings (bilateral with manager or senior examiner/expert or in plenum) and on the internal web.

21.09 Indicate whether top management or delegated officers of the Authority perform an internal review

of the QMS in accordance with paragraphs 21.22-21.25:

(a) at least once per year (cf. paragraph 21.22);

(b) in accordance with the minimum scope of such reviews as set out in Section 8, namely:

to determine the extent to which the QMS is based on Chapter 21 (cf. paragraphs 21.22, 21.24(i));

to determine the extent to which Search and Examination work complies with PCT Guidelines (cf.

paragraphs 21.22, 21.24(i));

(c) in an objective and transparent way (cf. paragraph 21.22);

(d) using input including information according to paragraphs 21.24 (ii)-(vi);

(e) recording the results (cf. paragraph 21.25).

a) Internal review is performed by delegated officers on different processes and organizational parts at least once a year. b) Reviews of patent processes or patent related functions shall always determine to what extent the QMS comply with all other rules and regulations for example; PCT Ch.21 Reviews of patent processes or patent related functions shall always include determination of compliance with all available rules and regulations i.e. Search and Examination work compliant with PCT Guidelines. c) Delegated officers are externally trained to perform objective and transparent reviews. At least one officer per review has no connection to the reviewed function / process. d) Input to reviews by delegated officers include information on corrective and preventive actions taken to eliminate cause of non-compliance, follow up actions from previous reviews, the effectiveness of the QMS itself and the process reviewed, feedback from customers and recommendations for improvement. e) Results from internal reviews are recorded by:


a) Internal review reports – fully accessible to all on intranet.

b) Non-conformities are addressed in our non-conformities database.

c) Customer input is addressed in customer input database.

d) Suggestions for improvement addressed in improvement database. Results from internal reviews serve as input to management reviews as well as external reviews.

2. RESOURCES

21.10 Explanatory note: The granting of ISA/IPEA status means that the Authority has demonstrated it

has the infrastructure and resources to support the search and examination process. Chapter 21 calls for

assurance that the Authority can continually support this process while accommodating changes in

workload and meeting QMS requirements. The responses below, should provide this assurance.

Human resources:

(i) Provide information about the infrastructure in place to ensure that a quantity of staff:

sufficient to deal with the inflow of work;

which maintains the technical qualifications to search and examine in the required technical fields;

and

which maintains the language facilities to understand at least those languages in which the

minimum documentation referred to in Rule 34 is written or is translated

is maintained and adapted to changes in workload.

(ii) Describe the infrastructure in place to ensure that a quantity of appropriately trained/skilled

administrative staff is maintained and adapted to changes in workload:

at a level to support the technically qualified staff and facilitate the search and examination

process, and

for the documentation of records.

It is important to declare that the QMS of the Swedish patent office is based on a purely process oriented view. The process owner is responsible of the process infrastructure and overall function of the process. The management of the Patent Department is responsible for assuring the quantity and the ability of resources. i) Demand, production and productivity are closely monitored on a weekly basis for every technical group, and every month for directorates and divisions. Dynamic allocation of resources is possible only if in accordance with technical and language qualification requirements. A computer based monitoring system concerning demand, combined with productivity algorithms, identifies resources needed at different technical groups or directorates at any given time. Additional information from a competence profile system and regular audits give management control over the dynamic allocation of resources, ensuring that allocation complies with the quality standards for search and examination. Examiners in technical groups have influence on production planning and are expected to give prompt feedback to management in case of indications of forthcoming workload issues.


Employment requirements guarantee technical and language qualifications necessary for search and examination within at least one technical field. A trial period of 6 months is applied for all employees. Search and examination staff passes through an 18 month internal education program including several examinations. In order to ensure that technical qualifications are maintained, an individual competence plan is used and evaluated on a yearly basis. Further training is documented and evaluated. A Patent expert program is conducted on regular basis. Examiners with exceptional skills in search and examination are selected to enter the program. The program is 3 years and ends with a written examination and the oral presentation of an advanced level thesis. Search and examination staff has language skills according to PCT regulations. The individual competence plan includes language updates if necessary. Staff is supported by computer based translation tools and in-house language experts. If necessary there is an option of using external translation experts. ii) The Formalities directorate as well as the Legal section support the technically qualified staff and facilitate the search and examination process. The infrastructure in place to ensure that the quantity of staff adapted to changes in workload is mainly based on Patent Department management meetings where managers from the technical directorates, the formalities directorate and the legal section discuss resource issues. Technically qualified staff supports the formalities directorate on a regular basis to ensure smooth operation and to ensure process optimization.

Material resources:

(iii) Describe the infrastructure in place to ensure that appropriate equipment and facilities such

as IT hardware and software to support the search and examination process are provided and

maintained;

(iv) Describe the infrastructure in place to ensure that at least the minimum documentation

referred to in Rule 34 is available, accessible, properly arranged and maintained for search and

examination purposes. State whether it is on paper, in microform or stored on electronic media,

and where.

(v) Describe how instructions:

to help staff understand and adhere to the quality criteria and standards; and;

to follow work procedures accurately and consistently

are documented, provided to staff, kept up-to-date and adapted where necessary.

iii) Support processes and functions are in place to support the search and examination process. An In-house IT function is responsible for IT soft- and hardware. The IT function is separated from the organization and a supplier-purchaser relationship is used to handle ordering and delivery conditions. The process owner acts as the purchaser for the Patent department. All internal IT systems are fostered by specially dedicated system administrators.

iv) The PRV has access to a vast amount of documentation that exceeds the minimum requirements set by the PCT and the Regulations. Most of the documentation is either stored electronically or can be accessed online. The PRV has a separate library and documentation section responsible for monitoring and updating documentation. (EPOQUE-net, Docdb:EPO)


v) All instructions;

As to help staff understand and adhere to quality criteria and standards as well as

To follow work procedures accurately and consistently;

are documented and provided to staff on the intranet. The instructions are presented in a process oriented view that gives staff an overview of what instructions are applicable at all parts of the process. The different instructions are evaluated on a continuous basis by different expert and cross referential groups. Any changes to instructions are documented and news flashed.

Training resources:

(vi) Describe the training and development infrastructure and program which ensures that all

staff involved in the search and examination process:

acquire and maintain the necessary experience and skills; and

are fully aware of the importance of complying with the quality criteria and standards.

vi) Examiners and Formalities staff take part in an effective initial training and development programme.

Newly recruited examiners follow a 18 month training program which includes theoretic parts and tutorial work. During this period the examiner is under the guidance of a tutor, who is responsible for the results of the examiner. There are two examination parts included in the program and also an evaluation of the work concluding efficiency and quality before nomination to become a patent examiner.

Detailed written training material and online training programmes support the in-house training. Refresher and update courses and seminars are held on a regular basis and initiated by either the quality manager, as a result of quality checks, or by management in response to new situations or guidelines. Directors provide individual educational programmes, in consultation with the individual, concerning both Intellectual Property Law and technical aspects. The educational programmes may include: workshops (in-house), examiner exchange, cross search/examining, inhouse/ external seminars and courses.

Patent experts are trained within a special expert programme attended by highly qualified examiners. The programme is extensive and runs over several years combined with normal search and examination duties. The programme ends with an examination and oral presentation of an examination thesis.

All staff are informed of the importance of complying with the quality criteria and standards as a part of the introduction to PRV course when they start their employment. The quality manager has a main responsibility to ensure that this knowledge is maintained, this is done by yearly quality information meetings.

Also there are practice discussions at meetings, quality checks, patent experts and search specialists that can be consulted in every technical field.


Oversight over resources:

(vii) Describe the system in place for continuously monitoring and identifying the resources

required:

to deal with demand; and

comply with the quality standards for search and examination.

vii) For long term (more than a year forward) the demand is predicted from monitoring and interpreting previous demand. Also, knowledge of the current and predicted state of the market is combined with statistical analysis (Holtz-Winther), to predict demand. The required resources are thereafter calculated with knowledge of previous production capacity using well-known macroscopic algorithms. On a shorter term the demand can be more precisely monitored by viewing actual demand values based on application databases. Also the resources are more precisely calculated by using the same algorithms as for long term production estimation but with more accuracy. A specific in-house computer program is used by the directors to calculate and match demand and resources on a technical field level. Updated Report on Quality Management Systems by the Swedish Patent and Registration Office (PRV) November 15, 2016 page 12 The system for continuously monitoring and identifying resources required complying with quality standards for search and examination is closely linked with the system for monitoring demand as described above. When we have sufficient resources to deal with demand this is a prerequisite to comply with quality standards. However PRV closely monitors changes and input regarding to quality standards. Resources needed to deal with quality issues i.e. training or measures that slows down production, these resources are input to the system.

3. MANAGEMENT OF ADMINISTRATIVE WORKLOAD

21.11 Indicate how the following practices and procedures for handling search and examination requests

and performing related functions such as data-entry and classification are implemented:

(i) Effective control mechanisms regarding timely issue of search and examination reports to a

quality standard as set by the respective Authority; and

(ii) Appropriate control mechanisms regarding fluctuations in demand and backlog

management.

i) All search and examination requests are monitored by each director, using an alert system with internal time limits set one month prior to PCT time limits. Lists of requests and their internal time limit are presented on individual, group and directorate level. Priority data is displayed in order to give an alert in cases of requests concerning risk of delay. Corrective action is taken. There is a follow-up system with feedback reports on any late requests. ii) Demand and backlog data is monitored and controlled by a separate controlling and statistics function, at individual/technical group level.


4. QUALITY ASSURANCE

21.12 The following are required quality assurance measures for timely issue of search and examination

reports of a quality standard in accordance with the Guidelines. Indicate how the following are

implemented, including the use of any checklists to verify reports before their issue or for monitoring the

quality standard as part of a post-issue review process:

(i) An internal quality assurance system for self-assessment, involving verification, validation

and monitoring of searches and examination work:

for compliance with these Search and Examination Guidelines;

for channeling feedback to staff.

(ii) A system of measurement and collection of data and reporting. Show how the Authority uses

the system to ensure the continuous improvement of the established processes.

(iii) A system for verifying the effectiveness of actions taken to correct deficient S&E work,

eliminate the causes, and to prevent issues from recurring.

i) For all applications a quality control is made by another examiner according to a computer based checklist, including check of search and examination guidelines. (“Second pair of eyes”) The checklist provides information if the second examiner agrees disagrees or has doubts within a certain number of checked fields. The information is stored for statistical data and feedback. However, the examiners and in some cases a patent expert always meet and analyze the results before any written communication is forwarded. As a complement to other quality assurance procedures, the process has been completed with a special procedure in the case the search results in only category “A” documents. The procedure involves consulting a patent expert and/or other technical expert going through the search strategy and parameters once again and if necessary doing complementary searching. The consultation and its measures are documented. Updated Report on Quality Management Systems by the Swedish Patent and Registration Office (PRV) November 15, 2016 page 13 As a part of quality assurance procedures, the “patent expert board” suggests and carries out yearly spot checks of the patent process. Patent experts and the patent expert board provide feedback to staff both on individual applications and on statistical analyses on the results of the quality control. ii) As described above data from quality checks in all application is stored and analyzed to provide feedback and continuous improvement of the patent process. All non-conformities and suggestions are also separately analyzed and form input to patent experts and staff on quality issues as to always improve the process. iii) Non-conformities are always fed into a separate system that has functionality to force the elimination of causes and to prevent deficient work to recur.


5. COMMUNICATION

Inter-Authority communication:

21.13 Explanatory note: Each Authority should provide for effective communication with other

Authorities.

(Note: This point is informative. No response is required by the template to paragraph 21.13)

21.14 Provide the name, job title and contact details of the Authorities designated quality contact person

who will take responsibility for:

(a) helping identify and disseminate best practice among Authorities;

(b) fostering continual improvement; and

(c) providing for effective communication with other Authorities to allow for prompt feedback

from them so that potential systemic issues can be evaluated and addressed.

Quality Contact person:

Christin Wendel [email protected] +46 (0) 8 782 26 38

Communication and guidance to users:

21.15 Describe the system in place for monitoring and using customer feedback including at least the

following elements:

(i) An appropriate system for

handling complaints and making corrections;

taking corrective and/or preventative action where appropriate; and

offering feedback to users.

(ii) A procedure for:

monitoring user satisfaction and perception; and

for ensuring their legitimate needs and expectations are met.

(iii) Clear, concise and comprehensive guidance and information to users (particularly

unrepresented applicants) on the search and examination process, giving details of where it is to

be found e.g. link to Authority’s web site, guidance literature.

(iv) An indication of where and how the Authority makes its quality objectives publicly available

for the users.

i) General complaints on PRV concerning customer relations, fees, opening hours etc. is handled by our IT based customer feedback system. All complaints concerning the handling of applications and the performance of the work done within the patent process are handled by our Process owner. All complaints are carefully documented and an investigation is carried out in all cases. The investigation is performed by the board of patent experts; the result is delivered to the process owner who communicates with the client. Corrections are made by the responsible examiner.

In case of preventive action needed the Process owner will set up a plan of action and the effectiveness of this plan will be checked at a later stage.


The customer will get a report on the complaint based on the investigation that has been undertaken. In some cases, if the investigation shows that PRV has made an obvious mistake, we can refund fees.

ii) Measurement of user satisfaction and perception is done by recurrent customer surveys, performed by a Swedish authority (SCB), every third year. PRV also document and measure any customer feedback from our customer feedback system. All feedback from customers is feed in to this system either by the customer, via a feedback forms on our website, or inputted to the systems by any employee according to specific instructions on customer feedback administration. PRV also holds customer meetings with representatives from industry, attorneys and inventors several times every year.

Our management system includes targets for the amount of realized customer suggestions.

Note that PRV mainly receives customer feedback via the customer feedback system and the customer meetings.

iii) PRV issues guidance booklets on the application, search and examination procedures. See also www.prv.se.

There are informative pages on the website on how to file a patent application as well as information of the patent process. Filers not using an attorney receive information with each action PRV makes. They also receive a welcoming letter with general information upon filing.

iv) See service commitments: http://www.prv.se/en/About-us/Vision-and-mission/Service-commitments/

21.16 Communication with WIPO and designated and elected Offices:

Describe how the Authority provides for effective communication with the International Bureau and

designated and elected offices. In particular describe how the Authority ensures that feedback is

promptly evaluated and addressed.

PRV uses the EDI system for all communication with WIPO concerning applications. All feedback from WIPO, normally mail or email is forwarded to the PCT administrative group, and immediately evaluated and addressed. In case of Legal aspects the feedback is forwarded to the Legal section. The Legal section also has several contacts within WIPO as to easily clarify and address any feedback.

6. DOCUMENTATION

21.17 Explanatory note: The QMS of the Authority needs to be clearly described and implemented so

that all processes in the Authority and the resulting products and services can be monitored, controlled,

and checked for conformity. This is done in the documents that make up the Quality Manual of the

Authority (see paragraph 21.18).

(Note: This point is informative. No response is required by the template to paragraph 21.17)

21.18 The documents that make up the Quality Manual serve to document the procedures and processes

affecting the quality of work, such as classification, search, examination and related administrative work.

In particular, the Quality Manual indicates where to find instructions on the procedures to be followed.

For the purposes of this report indicate:

(a) the documents making up a Quality Manual that have been prepared and distributed;

(b) the media on which it is supported (e.g. Internal Publication, Internet, Intranet); and

(c) document control measures taken e.g. version numbering, access to latest version.

Initial Report on Quality Management Systems by Fel! Hittar inte referenskälla. Month xx, 2012

16

PRV Quality Manual.

The Quality Manual of PRV is a document, called “Verksamhetsmanual”, only to be found on our intranet. It consists of numerous links to the actual parts of our Intranet where the actual processes and procedures are described. Below is a brief description of the Manual and its contents. When tagged with “link”, the headline has equivalence in one of our main links on the intranet (placed at the top menu)

a)

PRVs Business an overview A brief description of PRVs business and assigned tasks.

Words and Phrases Explanations of words and phrases in the manual

Main Processes Explanation of PRVs main processes and how we use processes for describing our business

Start – link Explanation on how you can personalize the start page of PRVs intranet.

News – link Explanation on the news area on the intranet

Organization - link Explanations concerning PRVs organization and organization chart, including responsibility and authority.

Management - link - Economic Explains the process of economic management

- Strategic Explains the process of Strategic management (3-5 years)

- Operative Explains the process of operational management (0-1 year)

VSAA-How we do it - link - Processes Design Processes Patent Processes National Process PCT Process – description o Laws and Rules o Guidelines - Search and Examination Guidelines(WIPO Pdf) o Working instructions o Examiners work area - Electronic memo card - Quality control notes - Language and electronic translators o Classification o Flowcharts o Manuals o Glossary/Index

Support - link Explains our support processes


My employment – link Explains what kind of information is presented concerning employment i.e. salary, vacation etc.

ISO 9001 Relates our quality management system to the ISO 9001:2015 requirements.

b) Intranet

c) Advanced document control in the intranet platform keeps track of any changes and presents version numbering and indication on latest version etc.

21.19 Indicate whether the documents making up the Quality Manual include the following:

(i) the quality policy of the Authority including a clear statement of commitment to the QMS from

top management;

(ii) the scope of the QMS, including details of and justification for any exclusions;

(iii) the organizational structure of the Authority and the responsibilities of each of its

departments;

(iv) the documented processes carried out in the Authority such as receipt of incoming

applications, classification, distribution, search, examination, publication and support processes,

and procedures established for the QMS, or references to them;

(v) the resources available for carrying out the processes and implementing the procedures;

and

(vi) a description of the interaction between the processes and the procedures of the QMS.

i) Yes ii) Yes iii) Yes iv) Yes v) Yes vi) Yes


21.20 Indicate which types of records the Authority maintains, such as:

(i) a definition of which documents are kept and where they are kept;

(ii) results of management review;

(iii) training, skills and experience of personnel;

(iv) evidence of conformity of processes, resulting products and services in terms of quality

standards;

(v) results of reviews of requirements relating to products;

(vi) the search and examination processes carried out on each application;

(vii) data allowing individual work to be tracked and traced;

(viii) records of QMS audits;

(ix) actions taken re. non-conforming products, e.g. examples of corrections;

(x) actions taken re. corrective action;

(xi) actions taken re. preventative action; and

(xii) search process documentation as set out in Section 7.

i) Yes, Intranet, Quality Manual ii) Yes, Intranet, Management process iii) Yes, Intranet, Management process, Patent process v) Yes, Intranet, Internal reviews vi) Yes, Intranet, Patent process, Application data support. vii) Yes, Intranet, Application data support viii) Yes, Intranet, Management process ix) Yes, Intranet, separate system for non-conformities, Olivia x) Yes, Intranet, separate system for non-conformities, Olivia xi) Yes, Intranet, separate system for non-conformities, Olivia xii) Yes, Intranet, search process documentation system


7. SEARCH PROCESS DOCUMENTATION

21.21 For internal purposes the Authority should document its search process.

The Authority should indicate

(a) which of the following are included in this record:

(i) the databases consulted (patent and non patent literature);

(ii) the keywords, combinations of words and truncations used;

(iii) the language(s) in which the search was carried out;

(iv) the classes and class combinations searched, at least according to the IPC or

equivalent;

(v) a listing of all search statements used in the databases consulted.

(b) which other information relevant to the search itself is included in this record e.g. a statement

of the subject of search; details of special relevance to internet searching; a record of documents

viewed; on-line thesaurus, synonym or concept databases, etc.

(Explanatory note: The IA is requested to list other information it may collect to monitor and

improve the search process)

(c) which special cases are documented and whether records are kept denoting any:

(vi) limitation of search and its justification

(vii) lack of clarity of the claims; and

(viii) lack of unity.

a)

i) Yes ii) Yes iii) Yes iv) Yes v) Search statements are partly listed if relevant to search results; full search history recording is available but not used.

b) Se appended print screens from PRV documentation tools. c) Se appended print screens from PRV documentation tools.

8. INTERNAL REVIEW

21.22 Explanatory note: The Authority should report on its own internal review arrangements. These

reviews determine the extent to which it has established a QMS based on the model of Chapter 21 and

the extent to which it is complying with the QMS requirements and the Search and Examination

Guidelines. The reviews should be objective and transparent to demonstrate whether or not those

requirements and guidelines are being applied consistently and effectively and should be undertaken at

least once a year. With reference to point 21.08 of this template, the Authority may provide additional

information on its internal review arrangements under this section if it so wishes.

21.23-21.25 These arrangements are reported according to this template in Section 1, above, at points

21.04 - 21.09. The Authority may provide additional information on further inputs to its internal reviews

under this section, if it so wishes.

Reviews are frequently conducted by delegated officers, see point 21.09.


9. ARRANGEMENTS FOR AUTHORITIES TO REPORT TO THE MIA

21.26 There are two stages in the reporting arrangements outlined in Chapter 21: the initial report called

for by paragraph 21.26(a), and supplementary annual reports in accordance with paragraph 21.26(b). At

the second informal meeting of the Quality Subgroup in Canberra on February 6 and 7, 2012, the

Subgroup recommended that, instead of submitting full reports every five years and cumulative updates

in the intervening years, Authorities should submit each report in the form of a full report, making the

differences from the previous year’s report clear, for example using “track changes” or other form of

highlighting. The template for the supplementary annual reports is therefore no longer used.

Appendix: Memo Card and Quality control software:




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